Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 2

Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children

Being proactive is generally a good idea. But in the absence of a definitive outbreak it is difficult to justify exposing pediatric patients to potential risks such as neurologic complications which may not show up for years. On a more practical level, working parents cannot afford to have their children out of school or daycare for 30 days.Even mothers at home commonly leave their children in mothers’ morning out programs or church daycare on Sunday potentially exposing a much greater number of individuals. I would not allow my children to participate nor would I encourage my patients to be involved. Dr. Marie Trenga

I do not think this vaccine should be tested on children, I think the majority of the vaccines we use currently have way too many health risks and the studies are not done to prove results for long term, or even neurological reactions, also 40 seems like too small of a population. Mrs. C Jones

I am opposed to the testing of any vaccine on anyone not of age to give informed consent. It is a gross violation of the Nuremburg Code. Most especially because it involves children should it not be done. I don’t need to explain all the medical reasons why this testing should not be done. The people involved know all that. I suggest they focus on the moral and ethical reasons it should not be done. Mrs. Lisa Jillani. People Advocating Vaccine Education

Even though you may argue that the proposed benefits vs risk warrants their use, until it is proven without a doubt that any vaccine is 100% safe, I and many other parents would prefer not to risk the health or lives of our children with this vaccine study. They are not guinea pigs! Therefore, we are strongly against Vaccine Study Docket No. 02N-0466. Thank you for your consideration. Samantha McTighe Carlsbad, CA

Instead of risking children, why not vaccinate healthy senior citizens who have already been immunized when they were children. If the vaccine didn’t harm them when they were young, odds are it won’t now. If this worked, then all the people who have previously been vaccinated could be revaccinated with no risk. That would remove a large group of people needing vaccine in the event of an emergency. It would also cover most of the leaders of the country, industry, etc. as they are probably older than 35, the age innoculations stopped. Mrs. Eileen Lenney

The recent finding that targeted vaccinations may be sufficient (Halloran et al., ‘Containing Bioterrorist Smallpox,’ SCIENCE, Nov. 15, 2002) assumes the traditional single initial infective person (Table 2, p. 1430), a historic fatality rate average of 30 percent in the unvaccinated majority (ibid.), and ordinary transmission by personal contact. These assumptions are flawed. The Tennessee Health Commissioner, Dr Fredia Wadley, recently said (emphasis added) that ‘When you have someone TRYING to transmit [smallpox] in an ABNORMAL way, then that sort of changes the picture…instead of one case you might have a thousand cases’ (end quote). We need a study that postulates a targeted population of confined susceptibles, efficient transmission by weaponized aerosols, massive initial cases, a high proportion of deadly hemorrhagic infections, and a fatality rate approaching 100 percent. –John Buder

No childrun should be used to test small pox Dryvax. This is a particularly dangerous and just plain ‘nuts’ suggestion. Anyone who supports this ought to have their own childrun at the head of the line. Perhaps if the Reality were not ‘other people’s childrun’ but ‘my own’, this would not have even been suggested. I absolutely object to this ‘study’. Dr. Demelza Costa

I think it would be a horrific violation of children’s rights to allow such testing to be done. It’s appalling that this question is even an issue in this day and age. Ms. Kim McCarthy I am very disturbed by the possibility of testing this vaccine in young children. We know that it causes side effects; those can be serious in adults. Why risk our children at this point? And if I understand correctly, there is some risk that the virus itself may be passed to other people–so if one child at daycare or a school participates in the test, other children may be exposed without parental knowledge or consent. Ms. Nicole Discenza

There is absolutely NO REASON to potentially KILL or DAMAGE our children. If an outbreak occurs let the parents decide at that time. Why would you people even consider using this nations children as lab rats? Mrs. Amy Tuttle

I can’t imagine any parent volunteering their child for this study. By the time a child is 5 years old, he/she has already been so bombarded with toxins in the form of inoculations, I think it would be absolutely criminal to subject these little ones to this study. These are little children, our future; not sacrificial lambs. I doubt there would be any children who would choose to participate in such a potentially dangerous endeavor. Why would any intelligent loving adult put them at such risk? And what happened to, “First, do no harm”? Do NOT go on with the proposed study! Mrs. Kathryn Snyder

Gelbmann Wolfgang [Wolfgang.Gelbmann@bifa.bmsg.gv.at] Sent: Friday, November 08, 2002 11:20 AM To: ‘fdadockets@oc.fda.gov’ Subject: clinical trial with smallpox vaccine Dryvax Dear Sirs! I would like comment on that. Is more information available about the background (aim) of this study anywhere on the HP of the FDA ? The ratio benefit (information?) in correlation to the risk for these children is not acceptable – in the current situation (to my knowledge). I agree that further dose response studies with the old smallpox vaccine stocks could be of high value (also for Europe, where some countries have large stocks of the old vaccine). But I do not understand why children should take part in this planned study. Best regards, Wolfgang Gelbmann Dr. Wolfgang Gelbmann, Assessor, Division Biomedical Assessment Federal Institute for Medicines, Possingergasse 38, A-1169 Vienna Tel: 0043 1 4920070 150, Fax: 0043 1 4920291

I feel that Dryvax should NOT be tested on children ages 2 to 5. First, according to the package insert, Dryvax has already been used in children under 5. So it appears to me that all the proposed research study would really do is determine if a watered-down version of Dryvax would be as effective as the full-strength version. If I am not mistaken, 680 adults have already participated in such a study, and this study showed the watered-down version to be 99.1% effective. Therefore, I feel that the proposed research study is unnecessary. It certainly does not justify putting these children in harms way. Second, children this young are apt to remove their bandages. I have a 2 year old child, and she will not leave any of her bandages alone. No amount of persuasion will sway her determination to pull one off. Once she has pulled it off, she will then proceed to pick at her hurt spot with her fingers. One time, she even managed to put the pulled-off bandage in her mouth before I could get it away from her (I was driving and she was in her car seat). If that particular bandage had had vaccinia virus residue on it, wouldn’t it have caused her to develop lesions (or worse) in her mouth or wherever else the bandage touched her body? Third, the parental consent form states that participating children should not attend day care or school for 30 days after vaccination. Shouldn’t they also be isolated from churches, grocery stores, playgrounds, neighbors, friends, relatives, baby-sitters, etc.? What about contact with their UNvaccinated parents and siblings? Is that safe?

How can you guarantee that they will not accidentally transfer the vaccinia virus to other children or adults, especially those who have scratches or cuts, are pregnant, or who suffer from eczema, dermatitis, cancer, AIDS, and other immune system problems, all of which are known contraindications to vaccinia and smallpox? And if that exposure caused damage to those people, who would pay for their care and recovery?

Fourth, the consent form states that if a participating child is injured because of this research study, medical care would be available, but would (and I quote) not necessarily be free of charge. Why not? It should be. I am not aware of any health insurance company that will cover the costs of complications resulting from experimental research. Fifth, the consent form states that, other than the small amount of money received for participating in the research study ($120-$160), financial compensation would not be available for an injured child. What if that child needed life-time medical care, or (God forbid) died, because of this research study? Compensation should definitely be available for any children that are damaged or killed by this proposed study. Thank you for allowing me to express my opinions. Mrs. J. Jones

I am writing you to protest the use of smallpox vaccinations. I am 32 years old, a US Citizen and the daughter of a retired/deceased Senior Chief Petty Officer in the US Navy who was stationed in Japan during the Vietnam War. In 1972, while living in Japan, I was vaccinated against smallpox. The smallpox vaccine caused me to be infected with smallpox. I am alive today, as is my sister who contracted the disease from me, but this is not the case for everyone who contracted the smallpox virus.

My concern is that as this is a live vaccine, like the oral polio vaccine, many people will become infected who may not survive: HIV/AIDS patients, cancer patients and others who are immunocompromised. I am a practicing pharmacist and am well aware of how important vaccinations are to the well-being of children, but I also am fully informed of how dangerous live vaccines are to the receiving them and to those who are in direct contact with the receiver. I know that smallpox is on the mind of every US Citizen but until we know that the benefit of the vaccination out-weighs the deaths that will result I must insist upon the FDA not approving any trials or programs, which vaccinate children against the smallpox virus. Thank you for your consideration, Traci Mitchell, Pharm.D.

I am strongly opposed to using children to test the weakened smallpox vaccine. If this is the same as the dryvac, I apologize for voicing my opposition at this site. The current supply should only be tested on a fully informed, carefully screened adult population given the potential for adverse side effects and spread of the smallpox lesion through improper care to the original inoculated site. I am a retired public health nurse and would hate to think that the Bush Adm. would be willing to take minority children and use them for guinea pigs in a “war on terrorism.” Shirley B.

I am appaled that the United States of America with all it’s wealth, knowledge would ever consider using innocent children to see if Dryvax, which has been kept in a freeze dried state since the 1960’s, works against a threat of small pox. As Vera Sharav, president of the Alliance for Human Research Protection said it is a CONTROVERSIAL VACCINE and is unconscionable!!!!! Nothing, nothing CONTROVERSIAL should ever, ever been give to CHILDREN!!!! Yes, we need to protect them, but my GOD find another way. Mr. Jenner who discovered the vaccine in the 1600’s by seeing young girls milking cows, who had coxpox, would if he could, get up from his grave and say, AMERICA, what has happened to our country that you would ever consider putting our CHILDREN at risk without the data to make sure they are SAFE!!!!!! In addition to the risk to children, what is this nonsense about a band-aid – if it came off the CHILDREN the virus could be lethal if spread to people who are immune compromised. Wake up AMERICA, HUMAN BEINGS are PRECIOUS, LIFE is PRECIOUS, please, please, please find another way to test 1960’s DRYVAX in order to protect our CHILDREN and our Adults. Thank You, Karen Podesta

This email is to advise you that I DO NOT support the smallpox vaccine study, Docket No. 02N-0466. I believe that the risks far outweigh any potential benefits. Thank you for your time and consideration. Sincerely, Jane A. Sherwin, RN

I believe that this study is dangerous, and that we should avoid exposure to small pox as long as we can, and it would be very unwise to reintroduce exposure to an eradicated virus. I also am firmly opposed to mandatory vaccination with this vaccine, if the issue arises. Mr. Christopher Masterjohn

I say NO to the smallpox vaccine.How dare you put children at risk as experiments in a clinical trail. Ms. Carol Caputo

I am opposed to testing on small children until a safer vaccine from a dead virus is developed. Ms. Debra Adler

I DO NOT support the smallpox vaccine study, Ms. Glory Leavins

I do not support the proposed trials on children for Docket No. 02N-0466. Edith Martin

I do not support the smallpox vaccine study, Docket# 02N-0466.Ray Gallup Lake Hiawatha, NJ

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466 Mrs. Sheila Ealey

I just wanted to let you know that I don’t think it is a good idea to use our precious children as guinea pigs for the smallpox vaccine. At this point, I don’t think the benefits of the study outweigh the risks. Thanks for your time. Sincerely, April Yeager

Before I even thought of having my child take the MILDER dose I would want to know ALL the side effects that the adults who took it had. And what risk there was to my child. As a parent, my children are PRECIOUS to me, a gift from God. I would want to protect them and would protect them at all costs. But I also would not want to expose them to something that could kill them if it didn’t help them. So, before we expose our children to this, we really need to find out all we can and then decide. Mrs. Lenora Day

All of this talk about forced immunization against smallpox makes me angry and afraid. Why are we talking about innoculating people with a dangerous vaccine just in case it is unleashed into our society? I think the government is overreacting to all of this. I am completely against ANY FORCED vaccination. I am angry about all of the vaccinations my child must have now before he can go to school. While I agree that vaccinations are basically a good thing, I don’t think we’ve given enough thought or study time to the long term effects of pumping our kids up with nearly 20 vaccines before the age of two. What does it do to their immune systems? The smallpox vaccine is known to have bad side effects and still these guys in the government are talking about forcing people to be vaccinated. It makes me angry. Many in the medical community have made the point that we can wait until we actually do come across smallpox before we vaccinate. . . Anyway, to answer your question specifically, I am against testing the vaccination on toddlers. I think that companies and the govt ought to put their heads together to make a safe smallpox vaccine first and then test it in other ways. Sorry for the diatribe but I needed to get my opinion in there. Ms. Mary Ellen Hegedus

I read an article in the Atlanta Journal Constitution on October 1, 2002 regarding a vaccine study planned for Children’s Hospital in Cincinnati and in LA. As a parent of a child injured by a live virus in a DPT shot in 1975 (Paul lived brain damaged and died at age four in 1979), I am very upset that children would be used in such a study. Ironically, I am from Cincinnati and my son died on June 2, 1979 at Children’s Hospital in Cincinnati.) The risks are too high to test such a vaccine on young children. There has to be another way to develop a safe vaccine for smallpox. Susan Rogers McCreary Atlanta, GA

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466. Joanna Jaicks Charleston, SC

I am a concerned citizen and am horrified as the prospect of the government performing “research” on our children using the small pox vaccination. I believe that this proposed research is dangerous not only to the children, but to anyone who comes into contact with them as the test will be performed with a live virus. With the lack of proven effectiveness of other vaccinations (as submission of any damaging effects is severely under-reported) I strongly oppose this experimentation and feel that our children would be better off developing an innate immunity. The potential danger of permanent neurological and physical damage is far to great for the possible ‘benefit’ that may never be tested. Sincerely, Nitha M. White D.C.

I understand there is a consideration to allow toddlers and preschool children to be used experimentally with smallpox vaccinations. This would be a deplorable action and should not be done. The children have no voice in the matter and what kind of parents would even allow this to happen. Please do not do this. Theresa Davidsen

Being one of the people who is at risk of contracting and dying from smallpox, if exposed, I am highly opposed to any smallpox vaccination being carried out just in case we have a terrorist attack some day. From what I have read, the vaccine is effective AFTER smallpox is contracted so why administer this at all and risk the population-at-large until it becomes absolutely, definitively necessary? And why experiment on children? Mrs. Kelly Ford

I do not believe that Dryvax should be tested on children at all! If the Smallpox vaccine is offered to the public, only those who are 18+ should be allowed to receive it. I cannot be exposed to Dryvax because I have Eczema. It could kill me. The last thing I want is a bunch of children putting my life at risk! This is an issue of the responsibility level. Children are not always that responsible and they will be more likely to not keep the bandage on at all times for two weeks. They could put other lives at risk, especially at school and in daycare. Granted, I am not around small children very much, but I do not want to be worried about keeping my distance in public (for example, the subway). Also, I do not see myself saying, Get away from me, I cannot be exposed to the Smallpox vaccine, to every single child that comes within a couple of feet of me. Ms. Katherine Owens

Although I understand the fear behind the testing, I would not want this experiment to be performed on my kids! Isn’t there a better solution? Why isn’t the jet injector being used in this study? The previous study showed less scarring, better results and no complications. How about a nonlive vaccine? This sure is an awful lot of pain and confusion to inflict on our young ones because of a bunch of what ifs. Mrs. Brandi Blaesing

This is a terrible idea. With all of the side effects that are already part of existing vaccines, and with the side effects that have been shown to come from the existing small pox vaccines, how anyone can ever consider injecting this material into young babies? The theory that vaccination is based on is flawed, and there is no point in exposing young children to these risks. This is a horrible idea. How can the people behind this sleep at night? This project is not worth the risk. Mrs. Lindsay Wolsey

I have no intention of allowing my child to participate in such a trial. I feel that is irresponsible to even suggest it. From my research, I do not feel this vaccine is safe, and I completely disagree with offering it to small children without a threat being present. Perhaps the FDA, Senate or Congress members would be willing to offer it to their own children?? Mrs. Jessica Smith

I had to re-read the news article to make sure I was not mistaken. You plan to test a live and admittedly dangerous vaccine on BABIES! Whose children? What parent would allow this abuse of their child? One pictures you tapping a source of unwanted children; Where would your ‘subject’ toddlers come from? The article has not stated if you have tested this dangerous dose on adults, if you have, has the wound site and/or the vaccine itself adversely or benificially impacted the adult test subjects. I think you should cease and desist this instant, you cannot ethically test this dose on little children!!! Mrs. Kathryn Bush

I would not knowingly submit my own child to a clinical trial involving aged vaccine stock. This is especially true because there has not been enough research done that will explain the effect the vaccine has in causing or exacerbating autoimmune responses. In addition, it seems to be entirely plausible to attempt to design and manufacture a dead virus vaccine which would make it more palitable to the general public. Ms. Christine Palermo

As a mother, I would never allow my children to be an actual part of a life-threatening study of this serious magnitude. Each person is given a small dosage of the disease in each vaccination. You could be the percentage that dies from the disease. I would never take that chance. I think immunization should be done away with due to many reports of children dying from polio after getting the polio vaccination. Mrs. Melanie Coopeer

Comments: It is my understanding that the Food and Drug Administration wants public comments on testing the small pox vaccine on toddlers and pre-schoolers. I feel this is a mistake, everything I have read about this vaccine points out all the possible risk and side effects involved. If this vaccine is going to be tested on humans I feel the first test subjects should be the public health officials who support this plan. . If more test are needed after that test it on the officials family members. Butler, Jennie C

I oppose testing the smallpox vaccine on young children — or on anybody. I believe the risks outweigh the gains. In fact, I think blanket vaccination of the public is a crime.

Why not educate the public? Smallpox is not as contagious as most peole fears. You have to be in close contact with someone for many hours. That means that anyone with a real risk of smallpox will know it and can get the vaccine afterwards. Thank you. Amy L. Lansky, Ph.D.

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